Kornimate/medical-research-clean huggingface dataset:
activity and quality of care indicators' for a sentinel network creation

Conditions: Obstetrics; Maternal Morbidity; Gynecology; Quality

Summary: there is no large-scale data in france or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. the creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research. the network will be designed to promote research in women's health and the emergency reception by focusing on: (i) assessment of the quality and organization of care and professional practice for the management of gynecological emergencies. (ii) the study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) comparison of organization systems gynecological emergencies departement between different high resource francophone countries (france, switzerland, belgium). (v) the assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

objectives : * to measure the incidence of the potentially life-threatening gynaecological emergencies (g-ple) and of the cases of severe morbidity (sm) * to analyze the determinants of the sm, * to validate an objective score of quality criterias of evaluation: * incidence of the g-ple and sm cases during one month. * reliability and validity of measurements of the indicators of quality of care. methodology: stage 1: data acquisition (prospective) within 22 gynaecological emergencies departments. stage 2: sampling and checking of files of patients included at stage 1 calendar of the research project: 18 months: * 6 months for the phase of preparation, * 1 month for the investigation of incidence, * 5 months for the phase of checking data, * 6 months of statistical analysis statistical analyzes: descriptive statistics of the data. estimation of the incidence rate of the potentially life-threatening gynaecological emergencies (g-ple) and of the cases of severe morbidity (sm) among women consulting for acute pelvic pain. to construct reliable quality indicators, principal components analysis and cronbach's α statistics will be performed to determine the underlying dimensions. construct validity of indicators will be assessed by testing predefined hypotheses about relationship between g-ple and or sm and quality indicators.

Eligibility criteria:
inclusion criteria: * french-speaking gynaecological emergencies departments leaned with a public maternity volunteers to take part in the study. * sample of files resulting from the principal centers recruiters exclusion criteria: -
a pilot study of roadmap 2.0 in oncology caregivers and patients

Conditions: Cancer; Quality of Life

Summary: this study will investigate the use of a mobile health app (roadmap 2.0) intervention in caregivers of patients with cancer. in this study participants will be given the roadmap 2.0 app, with a focus on the positive aspects of caregiving (positive activity components), and a fitbit. the primary objective of this pilot study is to test the feasibility and acceptability of using the mobile health app.

health information technology tools may enable caregivers and patients to become more active participants in their healthcare.this study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (roadmap 2.0).

Eligibility criteria:
inclusion criteria: 1. the caregiver must have an eligible patient (defined in items 5 - 9, below) 2. the caregiver must be of age ≥18 years. 3. the caregiver should be comfortable in reading and speaking english and signing informed consents. 4. the caregiver should provide at least 50% of care needs. 5. an eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). the caregiver who provides consent will be deemed the caregiver who participates in the study. in adolescents who are at the age to provide assent, she/he will designate the caregiver who provides \>50% of their care, and that caregiver will sign the consent document. 6. an eligible patient is age ≥5 years. 7. an eligible patient is able to sign informed consent/assent forms. 8. patients and caregivers agree to provide informed consent that is in regulatory compliance and irbmed-approved. 9. the caregiver and patient must have his/her own smartphone or tablet to participate.

Keywords: mobile health technology
a study of r1507 in participants with recurrent or refractory sarcoma

Conditions: Sarcoma

Summary: the study was primarily designed to determine objective response, progression-free survival (pfs), and the safety and tolerability of r1507 in participants with recurrent or refractory ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.


Eligibility criteria:
inclusion criteria: * progressive, recurrent or refractory ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma; * cohort 3 only: age must be \>= 2 and \<= 21 years exclusion criteria: * clinically significant unrelated systemic illness which would compromise the participant's ability to tolerate the investigational agent, or interfere with the study procedures or results; * known hypersensitivity to any of the components of r1507 or prior hypersensitivity reactions to monoclonal antibodies; * treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents; * current or prior therapy with insulin-like growth factor (igf) inhibitor (monoclonal or specific kinase inhibitor); * history of solid organ transplant; * other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer; * active central nervous system disease
toast:investigating the effect of bronchial thermoplasty on cough in patients with severe asthma

Conditions: Asthma Chronic, Cough

Summary: toast study is a pilot study aiming to establish the safety profile of using inhaled capsaicin challenge in patients with severe asthma. the investigators will also explore the differences in cough symptoms and threshold in patients with and without bronchial thermoplasty.

toast is designed as a two-visit observational study. during visit 1, written consent and measurements of baseline asthma characteristics were completed; history and examination, questionnaires (asthma control questionnaires and leicester cough questionnaire, and basic lung physiological assessment were performed. at the end of visit 1, a cough monitor was attached to the subject to monitor cough frequency for the next 24 hours and this was returned at visit 2. visit 2 followed within two weeks after visit 1, during which a full dose capsaicin cough challenge was performed. emergency contact details were given towards end of visit 2 should any adverse events occur. telephone call within 48 hours, day 3 and day 7: the purpose of these phone calls was to ensure that the patient had not developed any adverse effects to the capsaicin challenge.

Eligibility criteria:
inclusion criteria: * aged ≥18 * person with an established diagnosis of severe asthma * all patients should be on british thoracic society (bts) steps 4 or 5 * patients who have had bronchial thermoplasty (bt) should be at least 2 months after their treatment * historical evidence of one of the following: * airway reversibility to a short acting beta-2 agonist of ≥12% * bronchial hyper-responsiveness (pc20\<8mg/ml) * fractional exhaled nitric oxide ≥50ppb * peak flow variability \>8% * raised serum (≥0.45) or sputum eosinophilia (\>3%) * variability in spirometry over 24 months of \>20% exclusion criteria: * unable to give informed consent * fev1\<50% predicted or \< 1 litre * known allergy or intolerance to capsaicin * symptoms of upper respiratory tract infection in the last 1 month which have not resolved. * lower respiratory tract infection or pneumonia in the last 6 weeks. * current smoker or ex-smoker with ≥10 pack year smoking history, abstinence of ≤6 months * asthma exacerbation in the previous month requiring an increase or starting of an ics or ocs * subject has changed asthma medication within the past 4 weeks prior to screening * a previous asthma exacerbation requiring intensive care unit (icu) admission. * significant other pulmonary disorders as the major diagnosis, in particular: pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis. * evidence of vocal cord dysfunction * pregnancy or breast-feeding * use of ace inhibitors * any centrally acting medication which in the view of the investigator could alter the sensitivity of the cough reflex\* * history of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
effect of cinnamon extract on insulin resistance in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Insulin Resistance

Summary: the purpose of this study is to determine whether cinnamon from the cassae plant is effective in the body as insulin could lower blood sugar levels.

insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. as a result, blood sugar levels become abnormally high. insulin resistance is common in women with polycystic ovary syndrome (pcos). this study involves the administration of a nutritional supplement (cinnamon extract). the cinnamon extract like regular cinnamon powder comes from the bark of cinnamon cassae plant. it is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.

Eligibility criteria:
inclusion criteria: * 20 to 40 years of age * have a body mass index 25-40 kg/m2 * have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months) * history of irregular menstrual cycles (fewer than 6 cycles in past year) * excess androgen (to be measured at screening) * willing to supplement normal diet with cinnamon extract and a placebo for 12 weeks * you can stay overnight at pennington center three times over the next six months exclusion criteria: * do not meet our diagnostic criteria for polycystic ovary syndrome * have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible. * have cancer (active malignancy with or without concurrent chemotherapy). * abuse alcohol or illegal drugs. * smoke or have smoked within the previous 6 months. no smoking will be permitted during the study. * have donated blood within 30 days prior to randomization date. * have a hemoglobin, hematocrit, red blood cell, or iron level below the normal lower limit at screening. * taking medications that alter your glucose metabolism, (30 minute or more, 4 or more times per week over the past year.) * unwilling or unable to adhere to the clinical evaluation schedule over the entire six-month follow-up period.

Keywords: cinnamon pcos low blood sugar insulin glucose
faith moves mountains: an appalachian cervical cancer prevention project

Conditions: Cervical Cancer

Summary: the purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of pap smears among middle-aged and older appalachian women.

project development relied on principles of community based participatory research. participants were recruited from faith institutions in four distressed appalachian kentucky counties. investigators at the university of kentucky worked closely with local staff who implemented study procedures in the field.

Eligibility criteria:
inclusion criteria: * outside of cervical cancer screening guidelines at the time of study initiation * able to provide informed consent exclusion criteria: * history of cervical cancer * history of hysterectomy

Keywords: papanicolaou test cervical cancer screening randomized controlled trial faith-placed appalachia
vaccine against atherosclerosis in patients with overweight problems or obesity

Conditions: Atherosclerosis

Summary: atherosclerosis vaccine, v6, has been through two small-scale phase ii open label clinical trials. it has shown significant improvement in lipid profile in patients with overweight or obesity

the proposed study will evaluate daily dose of one v6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. the effect of v6 will be assessed by changes in lipid profile, i.e., ldl, hdl, tg and tc; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.

Eligibility criteria:
inclusion criteria: * baseline waist diameter over 90 and 80 cm for men and women, respectively exclusion criteria: * pregnant and lactating women * individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
heart failure self-care with the aid of a smartphone application

Conditions: Heart Failure

Summary: the purpose of this study was the development, and testing of a hf application that was used to provide self-care support to hf patients through a smartphone device. the study appraised current available literature on hf to determine best practices for promoting self-care of hf through direct communication with individuals with hf living at home. for the purpose of this study, smart phone communication was utilized. smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. this study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.


Eligibility criteria:
inclusion criteria: * living in a non-nursing home setting * primary providers of own self-care * established diagnosis of heart failure * cognitively intact * able to speak/write english exclusion criteria: * not willing to use a smartphone * not exhibiting acute decompensated heart failure symptoms
single-ascending dose study of amg 333 in healthy subjects and subjects with migraines

Conditions: Migraine

Summary: the primary purpose of this study is to determine whether amg 333 is safe and well tolerated in healthy subjects and subjects with migraines. as part of the secondary objectives, this study will characterize the pharmacokinetic (pk) profile of amg 333, as well as characterize the effect of amg 333 on the cold pressor test (cpt)-induced increase in blood pressure after single oral doses in healthy subjects and subjects with migraines

this is a randomized, double-blind, placebo-controlled, ascending single-dose study evaluating amg 333 in healthy subjects and subjects with migraines. the study will consist of 8 cohorts: 7 cohorts of healthy subjects and 1 cohort of subjects with migraines. for cohorts 1 to 7, 8 subjects each will be enrolled, and subjects will be randomized such that 6 subjects will receive amg 333 and 2 subjects will receive placebo (3:1 ratio). in cohort 8, up to 24 subjects with migraines will be enrolled, depending on enrollment rate and emerging safety and tolerability data. these migraine subjects will be randomized to receive amg 333 or placebo in a crossover fashion. both healthy and migraine subjects will be monitored in house for 4 days then allowed to return home for the remainder of the 14 day observation period. both healthy and migraine subjects will keep headache diaries.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the amgen physician. exclusion criteria: * history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator and amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy) or interfere with evaluation, procedures, or study completion.

Keywords: migraine
aliskiren in combination with losartan compared to losartan on the regression of left ventricular hypertrophy in overweight patients with essential hypertension

Conditions: Hypertension; Left Ventricular Hypertrophy; Overweight

Summary: to compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.


Eligibility criteria:
inclusion criteria: * patients with essential hypertension * patients with a bmi \> 25 kg/m2 * patients with lvh (lvwt ≥ 1.3 cm) confirmed by the echo exclusion criteria: * patients treated with an ace or an arb within 3 months of study entry (study visit 1) who are unable or unwilling to undergo the 3 month washout period. * patients treated with an ace and arb combination at study entry. * known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis). other protocol related inclusion/exclusion criteria applied to the study.
clinical effectiveness of papilocare® in regression of cervix hpv cytological abnormalities (papilobs gr).

Conditions: Papillomavirus Infections

Summary: the present study is a multicenter, open, non-interventional, prospective observational clinical study for the evaluation of the effectiveness of papilocare® (medical device with ce mark) in the regression of cervix cytological abnormalities caused by hpv.

524 participants were enrolled in the study from approximately 44 greek sites. at baseline (visit 1) written informed consent was obtained, participants' eligibility criteria were checked and medical history data were collected. participants were advised to be treated with papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months). at 6 months (visit 2) primary and secondary objectives were evaluated. if needed and based on physician's decision, treatment was extended to a total of 12 months (visit 3) and primary and secondary endpoints were evaluated as well.

Eligibility criteria:
inclusion criteria: women over 18 years of age who have been or not vaccinated against hpv. 1. able to read and understand the informed consent form and agree to participate in the study by signing the informed consent form. 2. patients with ascus or lsil routine cytological examination and positive high risk (hr) hpv molecular test, up to 3 months before inclusion in the study. 3. patients who, due to this condition, undergo a colposcopy and have a concordant result with cytology. exclusion criteria: 1. any gynecological or non-gynecological condition / lesion / pathology for which, according to clinical judgment, the use of papilocare® is not recommended or its use has contraindications. 2. fertile women who do not use effective contraceptive methods, pregnant women, women with suspected pregnancy or intention to become pregnant within the next 6 months, or breastfeeding women. 3. women who use vaginal contraceptives or other vaginal hormone treatments during the study. 4. participation in another clinical trial either currently or 4 weeks before enrolling in the study. 5. any scheduled surgery that precludes compliance with treatment. 6. known allergies to any of the ingredients of papilocare®.
effectiveness of t2* mri in cervical spondylotic myelopathy

Conditions: Cervical Spondylotic Myelopathy

Summary: utilization of t2\* mri in predicting prognosis in patients with cervical spondylotic myelopathy (csm)

cervical spondylotic myelopathy (csm), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. prognostic prediction is important because it affects subsequent treatment decision making. currently, prognosis is generally based on magnetic resonance imaging (mri) with a detailed macrostructural evaluation of the spinal cord. unfortunately, the use of conventional mri indicators (e.g., increased intensity signal \[isi\]) to predict csm outcomes has been controversial because of their subjectivity or the insufficient information contained therein. a new biomarker, t2\* mri gray matter to white matter signal intensity ratio (gm/wm), is associated with demyelination and gliosis. previous studies have shown that patients with csm can have t2\* mri wm / gm changes at the early stage of disease, and the wm / gm value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. however, the correlation between this index and long-term prognosis remains to be studied.

Eligibility criteria:
inclusion criteria: * diagnosed with csm and operated on by one senior orthopedist * available preoperative mri results * high-quality image data with no motion artifacts * available preoperative and long-term follow-up (≥1 years) mjoa score exclusion criteria: * prior head or neck surgery * a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).
could apnea induce hypoalgesia?

Conditions: Pain; Apnea

Summary: a randomized controlled trial (rct) in healthy subjects will be conducted with the following aims: (1) explore the effect of low pulmonary volume dynamic apnoea bouts on pressure pain threshold (ppt) and conditioned pain modulation (cpm); (2) analyse whether cpm response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts, rate of perceived exertion, hypoxemia and heart rate changes in ppt.

a randomized controlled trial (rct) in healthy subjects will be conducted with the following aims: (1) explore the effect of low pulmonary volume dynamic apnoea bouts on pressure pain threshold (ppt) and conditioned pain modulation (cpm); (2) analyse whether cpm response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts rate of perceived exertion, hypoxemia and heart rate changes in ppt

Eligibility criteria:
inclusion criteria: * healthy participants * 18-30 years * currently pain-free * basal spo2 ≥95% exclusion criteria: * diabetes diagnosis * hypertension or hypotension diagnosis * pharmacological treatment * frequent pain during last month * drug consumption * self-harming behaviours * pregnant or potentially pregnant * cardiac or respiratory pathology * splenectomy or spleen disease * having performed moderate or high intensity physical activity 24 hours prior to the study * not having slept the previous night * alcohol intake 24 hours prior to study.

Keywords: pain apnoea apnea hypoalgesia